Actively Recruiting
Study of AK119 Combined With AK112 in Patients With Advanced Solid Tumors
Led by Akeso · Updated on 2026-03-18
87
Participants Needed
1
Research Sites
215 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a Phase Ib/II study to assess the safety, tolerability and preliminary efficacy of AK119 combined with AK112 in patients with advanced solid tumors.
CONDITIONS
Official Title
Study of AK119 Combined With AK112 in Patients With Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily written informed consent and agree to comply with all protocol-specified procedures and follow-up evaluations
- Age 69 18 years and 64 75 years
- Histologically or cytologically-confirmed diagnosis of advanced/unresectable solid tumor that have been progressed or intolerant to at least one standard treatment regimen in the advanced or metastatic setting, if such a therapy exists
- Measurable lesion based on RECIST v1.1
- ECOG status of 0 or 1
- Life expectancy 69 3 months
- Adequate organ function
- Women of childbearing potential and men with female partners of childbearing potential must agree to use effective contraception during treatment and for at least 120 days following the last dose of study treatment
You will not qualify if you...
- Known other active malignancy within 3 years prior to the first dose of investigational product, except early stage cancers treated with curative intent
- Currently participating in another study unless it is observational, non-interventional, or a follow-up of an interventional study
- Received systemic antineoplastic therapy within 4 weeks prior to first dose; small-molecule anticancer agents within 2 weeks prior
- Prior exposure to immune checkpoint inhibitors other than anti-PD-(L)1 or treatments targeting tumor immune mechanisms
- Prior therapy targeting CD73, CD39, or the adenosine signalling pathway
- Treatment with NSAIDs, anti-platelet agents, or anticoagulants within 7 days prior to first dose
- Dependency on systemic glucocorticoids (>10 mg/day prednisone or equivalent) or other immunosuppressants within 14 days prior to first dose
- Presence of spinal cord compression or active brain metastases
- Uncontrolled pleural, pericardial effusion or ascites requiring repeated drainage
- History or presence of serious hemorrhage or bleeding tendency within 3 months
- Active autoimmune disease requiring systemic treatment in past 2 years
- Clinically significant cardiovascular disease
- History of interstitial lung disease or noninfectious pneumonitis
- Received systemic anti-infective therapy (excluding antiviral for hepatitis B or C) within 14 days prior to first dose
- Major surgery or serious trauma within 28 days prior to first dose
- History of immunodeficiency or HIV infection
- Active tuberculosis or syphilis infection
- History of organ transplantation or allogeneic hematopoietic stem cell transplantation
- Toxicities from prior anticancer therapy not resolved to Grade 1 or less
- Any other condition interfering with safety evaluation or study results
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China, 100005
Actively Recruiting
Research Team
T
Ting Liu, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here